The immense complexity of higher organisms requires extremely sensitive and sophisticated systems for regulating and integrating such processes as, for example, growth, regeneration, reproduction, and metabolic rate. Hormones are chemical messengers which play a crucial role in such regulation. Generally synthesized by specialized parts of the body called endocrine glands, they are carried throughout the body in the circulating blood and evoke specific responses in distant targeted tissues and organs. Human reproduction is a prime example of an extremely complex and highly integrated system finely coordinated by a set of interactive hormones. The nature and function of hormones which act on this system are continually being elucidated.
Recently, a previously unknown hormone termed Follicle Regulatory Protein, or FRP, has been identified. FRP is a protein secreted by the granulosal cells of the ovary which affects such reproductive functions in mammals as the production of sex hormones, growth and development of gametes, and ovulation. Unlike other hormones secreted by the reproductive organs, such as estrogen, which indirectly affect reproductive function by stimulating or inhibiting release of other hormones by endocrine organs such as the pituitary, it appears that FRP directly affects adjacent reproductive cells and tissues. FRP has been demonstrated to inhibit the maturation of ovarian follicles in females and spermatogenesis in males. FRP appears to be primarily responsible for the fact that in certain species, such as man, where single births are the norm, only one egg matures in the ovaries per menstrual or estrus cycle. Thus, FRP appears to have an important role in regulating the activity of normal reproductive cells.
The human reproductive tract is subject to numerous types of malignancies, many of which are difficult to detect and carry a high mortality rate. Two of the most common are ovarian and testicular cancers which result from neoplasms of gonadal cells; together such cancers will account for some 12,000 projected deaths in the United States in 1986.
Surgical removal is currently the only effective treatment for most reproductive malignancies. However, because the tumors are internal, such cancers often remain undetected until the tumor has grown and spread to such an extent that surgical correction is ineffective or impossible. Chemotherapy, while potentially effective in some cases, has limited activity in most patients and is associated with considerable toxicity and undesirable side effects resulting from the wide ranging effects of such treatment.
There thus remains a long-felt need for a method of treating abnormal cell growth of the mammalian reproductive tract which is effective and carries few side effects. The present invention satisfies these needs and provides other related advantages as well.